Plaquenil Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Plaquenil Indications
Indications
Plaquenil Dosage and Administration
Adult
Children
Plaquenil Contraindications
Not Applicable
Plaquenil Boxed Warnings
Not Applicable
Plaquenil Warnings/Precautions
Warnings/Precautions
Cardiomyopathy. Ventricular arrhythmias. Avoid in patients with congenital or documented acquired QT prolongation and/or known risk factors for QT prolongation (eg, heart failure, MI, bradycardia, ventricular dysrhythmias, uncorrected hypokalemia and/or hypomagnesemia). Risk for retinal damage if daily dosage is ≥5mg/kg, duration of use >5yrs, renal impairment, concurrent macular disease. Monitor for ocular toxicity, cardiotoxicity, and renal toxicity; discontinue if suspected or demonstrated by tissue biopsy. Correct electrolyte imbalances prior to initiation. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis); discontinue if reactions occur. Avoid in those with psoriasis or porphyria. Hepatotoxicity associated with porphyria cutanea tarda. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use; discontinue if myelosuppression, muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. History of psychiatric disorders. Hypoglycemia; monitor diabetics. G6PD deficiency. Hepatic or renal impairment; may need dose reduction. Elderly. Pregnancy. Nursing mothers.
Plaquenil Pharmacokinetics
Absorption
Following a single, oral Plaquenil 200 mg dose, whole blood hydroxychloroquine Cmax was 129.6 ng/mL (plasma Cmax was 50.3 ng/mL) with Tmax of 3.3 hours (plasma Tmax 3.7 hours).
Distribution
Extensively distributed to tissues; large volume of distribution. Plasma protein bound: ~50%.
Elimination
Renal. Half-life: 40–50 days.
Plaquenil Interactions
Interactions
Plaquenil Adverse Reactions
Adverse Reactions
Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; cardiomyopathy, irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), severe skin reactions, hematologic toxicity, hemolytic anemia, neuropsychiatric reactions (suicidality).
Plaquenil Clinical Trials
See Literature
Plaquenil Note
Not Applicable
Plaquenil Patient Counseling
See Literature
Plaquenil Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Plaquenil Indications
Indications
Limitations of Use
Plaquenil Dosage and Administration
Adult
Children
Plaquenil Contraindications
Not Applicable
Plaquenil Boxed Warnings
Not Applicable
Plaquenil Warnings/Precautions
Warnings/Precautions
Cardiomyopathy. Ventricular arrhythmias. Avoid in patients with congenital or documented acquired QT prolongation and/or known risk factors for QT prolongation (eg, heart failure, MI, bradycardia, ventricular dysrhythmias, uncorrected hypokalemia and/or hypomagnesemia). Risk for retinal damage if daily dosage is ≥5mg/kg, duration of use >5yrs, renal impairment, concurrent macular disease. Monitor for ocular toxicity, cardiotoxicity, and renal toxicity; discontinue if suspected or demonstrated by tissue biopsy. Correct electrolyte imbalances prior to initiation. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis); discontinue if reactions occur. Avoid in those with psoriasis or porphyria. Hepatotoxicity associated with porphyria cutanea tarda. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use; discontinue if myelosuppression, muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. History of psychiatric disorders. Hypoglycemia; monitor diabetics. G6PD deficiency. Hepatic or renal impairment; may need dose reduction. Elderly. Pregnancy. Nursing mothers.
Plaquenil Pharmacokinetics
Absorption
Following a single, oral Plaquenil 200 mg dose, whole blood hydroxychloroquine Cmax was 129.6 ng/mL (plasma Cmax was 50.3 ng/mL) with Tmax of 3.3 hours (plasma Tmax 3.7 hours).
Distribution
Extensively distributed to tissues; large volume of distribution. Plasma protein bound: ~50%.
Elimination
Renal. Half-life: 40–50 days.
Plaquenil Interactions
Interactions
Plaquenil Adverse Reactions
Adverse Reactions
Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; cardiomyopathy, irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), severe skin reactions, hematologic toxicity, hemolytic anemia, neuropsychiatric reactions (suicidality).
Plaquenil Clinical Trials
See Literature
Plaquenil Note
Not Applicable
Plaquenil Patient Counseling
See Literature
Plaquenil Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Plaquenil Indications
Indications
Plaquenil Dosage and Administration
Adult
Children
Plaquenil Contraindications
Not Applicable
Plaquenil Boxed Warnings
Not Applicable
Plaquenil Warnings/Precautions
Warnings/Precautions
Cardiomyopathy. Ventricular arrhythmias. Avoid in patients with congenital or documented acquired QT prolongation and/or known risk factors for QT prolongation (eg, heart failure, MI, bradycardia, ventricular dysrhythmias, uncorrected hypokalemia and/or hypomagnesemia). Risk for retinal damage if daily dosage is ≥5mg/kg, duration of use >5yrs, renal impairment, concurrent macular disease. Monitor for ocular toxicity, cardiotoxicity, and renal toxicity; discontinue if suspected or demonstrated by tissue biopsy. Correct electrolyte imbalances prior to initiation. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis); discontinue if reactions occur. Avoid in those with psoriasis or porphyria. Hepatotoxicity associated with porphyria cutanea tarda. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use; discontinue if myelosuppression, muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. History of psychiatric disorders. Hypoglycemia; monitor diabetics. G6PD deficiency. Hepatic or renal impairment; may need dose reduction. Elderly. Pregnancy. Nursing mothers.
Plaquenil Pharmacokinetics
Absorption
Following a single, oral Plaquenil 200 mg dose, whole blood hydroxychloroquine Cmax was 129.6 ng/mL (plasma Cmax was 50.3 ng/mL) with Tmax of 3.3 hours (plasma Tmax 3.7 hours).
Distribution
Extensively distributed to tissues; large volume of distribution. Plasma protein bound: ~50%.
Elimination
Renal. Half-life: 40–50 days.
Plaquenil Interactions
Interactions
Plaquenil Adverse Reactions
Adverse Reactions
Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; cardiomyopathy, irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), severe skin reactions, hematologic toxicity, hemolytic anemia, neuropsychiatric reactions (suicidality).
Plaquenil Clinical Trials
See Literature
Plaquenil Note
Not Applicable
Plaquenil Patient Counseling
See Literature
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